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(PHO-0702) The DHA Study

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Docosahexaenoic Acid (DHA) Reduces Inflammation and Aromatase Expression in Subcutaneous Fat and Inflammation in the Rectosigmoid Mucosa in Obese Postmenopausal Women: a Pilot Study

Principal Investigator:
Peter R. Holt M.D.

Jeanne Walker ANP-C

Contact Information:
Clinical Research Support Office
1230 York Avenue
New York, NY 10065
Telephone: 1-800-RUCARES
Enrollment Status:
Closed to Enrollment

Brief Summary of Protocol:
Breast cancer and colon cancer are two of the most common cancers in the United States. Breast cancer occurs at all ages but is particularly common in post menopausal women. Obesity increases the risk of breast cancer primarily of the type stimulated by the female sex hormone, estrogen. In obesity, fat cells produce estrogen which may promote cancer in the breast tissue, while reducing estrogen lowers the incidence of breast cancer. Inflammation (swelling) of fat tissue and the blood vessels of the heart are also seen with obesity. Based on studies in animals, reducing inflammation in the fat tissue in obese women might lower estrogen levels and the risk of breast cancer. Obesity at the same time also increases the inflammation of colon tissue. Since chronic inflammation in the colon increases the chance of developing rectal and colon cancers, reducing inflammation should lower the risk of developing these cancers as well. Omega-3 fatty acids are considered essential fatty acids and we need them for our bodies to work normally. They are not made in the body. We receive them through food, primarily in fatty fish. A diet high in omega-3-fatty acids has been shown in mice to reduce inflammation and estrogen formation in fat tissue. It also reduces inflammation in the colon of both mice and humans. Therefore, this study aims to determine if a nutritional supplement of an omega-3-fatty acid (docosahexaeonic - DHA) lowers inflammation in human fat and colon tissue thereby lowering estrogen production and the risk potential for breast, rectal and colon cancers.

Detailed Description of Protocol:
Participation includes:
- Two, 3-day inpatient stays at The Rockefeller University Hospital (private room)
- Fat biopsies
- Taking Omega-3 Fatty Acid

What specifically makes a person eligible for the study?
You may be eligible to enter this study:

- Post-menopausal
- BMI of 30-40
- Have not been diagnosed with Diabetes
- HIV negative
- Have not been diagnosed with a bleeding disorder



Children permitted to participate:

Potential Benefits.....
You will gain a better knowledge of your health status through the comprehensive physical examination, and blood and urine tests performed during the study. A copy of the standard New York certified laboratory tests will be made available to you if you would like a copy of them.

Compensation is provided.